Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

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Zoster Vaccines Session: Introduction

ACIP Meeting

October 20, 2021

Camille Nelson Kotton, MD

Chair, Herpes Zoster Work Group
2021 Herpes Zoster Work Group

2

ACIP Members

Camille Nelson Kotton, MD (Chair)

Lynn Bahta, RN, MPH

Grace Lee, MD, MPH

Ex Officio Members

Paula Agger, MD, MPH FDA

Jeffrey Cohen, MD NIH

Darcie Everett, MD, MPH FDA

Jeffrey Kelman, MD CMS

Liaison Representatives

Carol Baker, MD IDSA

Mary Pat Friedlander, MD AAFP

Sandra Fryhofer, MD ACP/AMA

Elizabeth Rausch-Phung, MD, MPH AIM

William Schaffner, MD NFID

Kenneth Schmader, MD AGS

Adam Welch, PharmD APhA

Invited Consultants

Edward Belongia, MD

Al Benson, MD

Paul Cieslak, MD

Jeffrey Curtis, MD, MPH

Jay Fishman, MD

Rafael Harpaz, MD, MPH

Kelly Moore, MD, MPH

Vicki Morrison, MD

Steven Pergam, MD

Lisa Prosser, PhD

CDC Lead

Tara Anderson, DVM, MPH, PhD
Timeline of Recombinant Zoster Vaccine (RZV, Shingrix)

Oct 2017

FDA 

licensure

Jan 2018

CDC adopts ACIP 

recommendation

Aug 2020

European Medicines 

Agency approves expanded 

RZV indication (adults ≥18y 

at increased risk of HZ)

Fall 2020 

Supplemental biologics license 

application submitted to FDA to 

support RZV use in IC adults ≥18y

Feb 2021

RZV in IC policy 

question and EtR 

introduced to 

ACIP

3

Abbreviations: HZ-Herpes Zoster; IC-Immunocompromised; RZV-Recombinant Zoster Vaccine; EtR-Evidence to 

Recommendations Framework

Clinical trials and evidence generation involving use of RZV among 

immunocompromised populations

Jul 2021

FDA approves 

expanded RZV 

indication for use in IC 

adults ≥18y
Policy Question

4

▪ Should adults aged ≥19 years who are or will be immunodeficient or 

immunosuppressed due to disease or therapy be recommended to 

receive two doses of recombinant zoster vaccine for the prevention of 

herpes zoster and its complications?

▪ Including but not limited to:

1. Hematopoietic stem cell transplant (HSCT) recipients

2. Patients with hematologic malignancies (HM)

3. Renal or other solid organ transplant (SOT) recipients

4. Patients with solid tumor malignancies (STM)

5. People living with HIV

6. Patients with primary immunodeficiencies, autoimmune and inflammatory 

conditions, and taking immunosuppressive medications/therapies
PICO Question

5

Population Immunocompromised (IC) adults aged ≥19 years

Intervention Recombinant zoster vaccine (RZV), 2 doses at least 4 weeks apart*

Comparison No vaccine

Critical 

Outcomes

• Herpes Zoster (HZ)

• Serious Adverse Events (SAEs)

Important 

Outcomes

• Postherpetic Neuralgia (PHN)

• HZ-Related Hospitalization

• Immune-Mediated Disease (IMD)

• Reactogenicity (Grade 3)

• Graft versus Host Disease (HSCT)

• Graft Rejection (SOT)

*First dose at Month 0 followed by a second dose 2 to 6 months later; For individuals who are or will be immunodeficient or immunosuppressed 

and who would benefit from a shorter vaccination schedule: First dose at Month 0 followed by a second dose 1 to 2 months later.
▪ Economics of 

vaccinating IC 

19–49-year-old 

adults against 

HZ in the US

▪ Preliminary EtR 

regarding use of 

RZV in IC adults 

≥19 years

September 2021 ACIP Meeting

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EtR: Evidence to Recommendations Framework
▪ Two work group meetings

▪ Reviewed and discussed

–September 2021 ACIP feedback

–EtR updates

–Considerations for use of RZV in IC adults

–Proposed policy options

Activities since September 2021 ACIP Meeting

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▪WG Interpretation of the EtR Regarding Use of RZV in 

Immunocompromised Adults, Considerations for Use, and 

Proposed Policy Options

▪Discussion

▪ACIP vote later in meeting

Today’s Session

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▪ ACIP HZWG: Paula Agger, Robin Avery, Lynn Bahta, Carol Baker, Edward Belongia, Al 

Benson, Paul Cieslak, Jeff Cohen, Jeff Curtis, Jeff Duchin, Darcie Everett, Jay Fishman, 

Mary Pat Friedlander, Sandra Fryhofer, Rafael Harpaz, Jeff Kelman, Grace Lee, Vicki 

Morrison, Kelly Moore, Steve Pergam, Lisa Prosser, Elizabeth Rausch-Phung, Bill 

Schaffner, Ken Schmader, Adam Welch

▪ HZWG CDC Lead: Tara Anderson

▪ CDC, Other Contributors: Jessica Anderson, Stephanie Bialek, Doug Campos-Outcalt, 

Tom Clark, Amanda Cohn, Janine Cory, Kathleen Dooling, Jonathan Duffy, Richard 

Forshee, Jack Gersten, Angela Guo, Theresa Harrington, Alexandra Hess, Laura 

Hurley, Shainoor Ismail, Lisa Jackson, Tara Jatlaoui, Andrew Kroger, Andrew Leidner, 

Jessica Leung, Megan Lindley, Jessica MacNeil, Mona Marin, Karen Mason, Nina 

Masters, Rebecca Morgan, Jennifer Nelson, Ismael Ortega-Sanchez, Paul Rota, 

Coleman Rotstein, Jeanne Santoli, Leah Shepersky, Tom Shimabukuro, John Su, 

Joanna Taliano, Megan Wallace, Eric Weintraub

Acknowledgments

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1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.

Thank You